IAHCSMM VIEWPOINT
OR buying new reusable instruments or equipment? Have SPD weigh in fi rst.
by Julie E. Williamson
t’s an all-too-common conundrum: Sterile Processing (SP) professionals discover too late in the acquisition cycle that new surgical instruments or equipment have been purchased – with- out those in the Operating Room (OR) or other user departments fi rst ensuring S technicians have the knowledge, training, instructions for use (IFU) (and, sometimes, even the required processing equipment) to ensure it can be cleaned and sterilized safely and effectively.
I Numerous factors can contribute to this
glaring oversight (one that, by the way, can jeopardize patient safety and place the healthcare organization at signifi cant liability risk). For starters, it’s not uncom- mon for physicians/surgeons to demand certain devices or equipment based on their experience with them at previous facilities, and for their current facility to then cater to their wishes without fi rst con- sidering all implications of the purchase. Lack of SP visibility and presence within the facility can also play a key role. In some cases, SP professionals aren’t actively involved in multidisciplinary committees, so they may be either simply unaware of product evaluation or purchasing discus- sions, or don’t want to rock the proverbial boat by interjecting their opinions, objec- tions or concerns. What’s more, not all facilities have effective, enduring partner- ships between SP, the OR and Infection Prevention (IP), an unfortunate reality that can perpetuate an “us and them” percep- tion that erodes effective, proactive com- munication across all sides of business. Over the years, the International Asso- ciation of Healthcare Central Service Mate- riel Management (IAHCSMM) has heard numerous examples of near-disastrous consequences stemming from new pur- chases being made without fi rst consulting with those in the SP department (SPD). Some shared how new reusable devices or equipment made their way into the department for initial processing, only to discover the SPD lacked the required
equipment to clean, high-level disinfect or sterilize the item according to the manu- facturer’s IFU. One SP professional shared how a surgeon became infuriated when told the SPD didn’t have the proper equip- ment to process the new device safely and properly. The surgeon sternly suggested the SPD process it with the equipment they had (a request that was promptly and prudently denied by the SP manager who reiterated the need to follow IFU, standards and best practices to the letter).
Stakeholders must step up SP professionals who don’t currently participate in detailed discussions on new product selection, evaluation and, ultimately, purchase need to take steps now to ensure they have a regular seat at the table (if any efforts to participate are met with resistance, it can be helpful to seek support from IP). Every instrument or piece of equipment that would require reprocessing by SP professionals must be carefully assessed prior to purchase and acquisition to ensure the technicians have the resources (e.g., supplies, equipment, training, IFU, etc.) to manage the new item(s) safely and consistently. ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, recommends healthcare organizations establish a multidisciplinary product evaluation committee that has represen- tation from those who will be affected by the new product.1
For a product that
would undergo steam sterilization, for example, the committee could consist of someone from the SPD, the OR, IP, Risk Management, Materials Management, Staff Development, and potentially others. During the evaluation process, it is rec- ommended to ensure all stakeholders have access to critical data that includes clearance documentation from the US Food and Drug Administration; the manufacturer’s litera- ture and written IFU for the product being evaluated; expert opinions and relevant
research published in peer-reviewed jour- nals; and reports from peers who are cur- rently using the product or have trialed it.1 The following factors should also be considered before a facility procures a new product1
:
• How the new product will contribute to patient care and safety;
• Legal concerns or safety implications that could arise from the product’s use;
• Product’s expected return on investment; • Education/training needed to ensure all staff members can safely and effectively use the product;
• Product’s ease of use and compatibility with the facility’s existing equipment and products;
• Product’s environmental impact; • Availability of ongoing vendor support (e.g., for training or maintenance); and
• The new product’s impact on inventory standardization.
Conclusion New product and equipment purchases are ongoing and necessary to keep healthcare organizations competitive and current with the latest medical/surgical procedures and industry trends that impact the delivery of patient care. It is essential, however, that new product evaluations and purchasing decisions never occur in a vacuum but rather with multidisciplinary involve- ment that includes representation from all disciplines that would be impacted by the purchasing decision. Only then can facilities help ensure that the purchasing decision is one that meets the broader needs and pri- orities of the organization and the patients it serves. HPN
References
1. ANSI/AAMI ST79:2017, Comprehensive guide to steam steril- ization and sterility assurance in health care facilities. Section 15, New product evaluation.
Julie E. Williamson serves as Senior Editor and Director of Communications for the Interna- tional Association of Healthcare Central Service Materiel Management.
hpnonline.com • HEALTHCARE PURCHASING NEWS • February 2021 53
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